A Community-Based Intervention to Reduce Alcohol Use in Vietnamese Men

NCT06713304 | Not Yet Recruiting

• 1 other identifier: FONCU2601
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. In this randomized controlled trial, 104 men aged 35-44 years, identified as having HAU (Alcohol Use Disorders Identification Test score = 8-15), will be recruited from a rural area in Thai Nguyen province, Vietnam. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group using stratified blocked randomization. The intervention group will participate in a community-based PBS program, which includes five weekly 90-minute sessions, with Short Message Service (SMS) reminders sent three times weekly after each session to reinforce PBS practices. The control group will receive usual care only. The primary outcome is alcohol use, assessing both the quantity and frequency of consumption, measured at 1 month and 3 months post-intervention. Secondary outcomes include the severity of alcohol-related problems and intention to use alcohol. These will be assessed at baseline and the 3-month follow-up. Two-way repeated measures Multivariate analysis of variance (MANOVA) and regression models will be conducted to evaluate the effects of the intervention on the primary and secondary outcomes.

Conditions

Alcohol Use

Keywords

Alcohol use; Protective Behavioral Strategies; Adult Men

Outcome Measures

Primary Outcomes (1)

• Alcohol use

  Alcohol use is measured by both the amount and frequency of alcohol consumption. The amount of alcohol use is quantified as the total grams of pure alcohol that participants consumed per week in the previous month measuring at baseline, 1 month, and 3 months post-intervention. This is calculated using the formula: Volume (ml) × ABV(%) × 0.79, where ABV is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol. Frequency of alcohol use is defined as the number of days per week in the previous month that participants consume alcohol measuring at baseline, 1 month, and 3 months post-intervention. These variables are measured using the Alcohol Timeline Follow back (TLFB).

  Baseline, 1 month and 3 months post-intervention

Secondary Outcomes (2)

• Severity of alcohol-related problems

  Baseline and 3 months post-intervention

• Intention to use alcohol

  Baseline and 3 months post-intervention

Study Arms (2)

A Community-Based Protective Behavioral Strategies Program

EXPERIMENTAL

Participants receive the community-based Protective Behavioral Strategies program

Behavioral: A community-based Protective Behavioral Strategies program

Control Group

NO INTERVENTION

Participants receiving the usual care

Interventions

A community-based Protective Behavioral Strategies program BEHAVIORAL

A 5-week group program delivered in a healthcare setting to teach and practice protective behavioral strategies. The objectives of each session are: Session 1: Setting Safe Drinking Limit: The participants can identify the risk related to their drinking behavior, calculate a standard drink, and set a safe drinking limit. Session 2: Choosing Nonalcoholic Drinks: The participants can understand the benefits of using nonalcoholic beverages and identify and select nonalcoholic beverages. Session 3: Planning Ahead: The participants can make a plan to stop using during drinking events and know how to say "no" to alcohol use. Session 4: Slowing down drinking: The participants can understand the benefits of slowing down drinking and know how to slow down their drinks. Session 5: Avoid Risky Drinking Situations: The participants can understand the negative effects of excessive drinking and know how to avoid excessive drinking.

A Community-Based Protective Behavioral Strategies Program

Eligibility Criteria

• Age: 35 Years - 44 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having a total AUDIT score from 8 to 15
• Completing at least primary school
• Able to use the Vietnamese language
• Having a mobile phone
• Willing to participate in this study

You may not qualify if:

• Using alcohol and other illicit drugs at the same time
• Having any physical illness or psychiatric disorders

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University, Faculty of Nursing

Bangkok, Bangkok, Thailand, 10330, Thailand

Location

MeSH Terms

Conditions

Alcohol Drinking; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Central Study Contacts

Trieu Van Nhat, PhD. Candidate

CONTACT

(+84) 368271372; 6578304436@student.chula.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: the IPD and supporting information will be available 6 months after the publication of primary results and will remain accessible for 2 years.
• Access Criteria: Researchers with a valid scientific purpose may access the de-identified IPD and supporting information upon submission of a data-sharing request. Requests should include a research proposal and the intended use of the data.

Locations

TH (1)